NCT04218045

Brief Summary

Evaluation of the advantages, disadvantages and complications of a recently innovated procedure (Single anastomosis sleeve ileal "SASI" bypass) of the more traditional laparoscopic sleeve gastrectomy "LSG"

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 6, 2020

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

January 8, 2019

Last Update Submit

December 31, 2019

Conditions

Bariatric Surgery

Keywords

sleevelaparoscopySASIMorbid obesitymetabolic surgerygastrectomy

Outcome Measures

Primary Outcomes (4)

  • operative time

    duration of operation by each technique (in minutes)

    the day of operation only

  • intra-operative complications

    incidence of intra-operative adverse events e.g. bleeding, visceral injury

    the day of operation only

  • Post-operative complications

    incidence of post operative complications (Most importantly leakage) other complications e.g. bleeding, thrombo-embolism, chest complications, wound infection...

    within 12 weeks of the operation

  • Percentage of Excess Weight Loss (%EWL)

    Percentage of weight loss during the year after operation, calculated as a percentage of the excess weight estimated before operation (in kilograms)

    within 1 year of the operation

Secondary Outcomes (2)

  • change in co-morbidities

    within one year of the operation

  • incidence of anemia, protein or vitamin deficiency

    within one year of the operation

Study Arms (2)

Laparoscopic sleeve gastrectomy group

ACTIVE COMPARATOR

The group of morbidly obese patients undergoing laparoscopic sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomy

SASI bypass group

EXPERIMENTAL

The group of morbidly obese patients undergoing laparoscopic single- anastomosis sleeve ileal bypass (the new procedure being evaluated)

Procedure: Laparoscopic single anastomosis sleeve ileal bypass

Interventions

Laparoscopic single anastomosis sleeve ileal bypassPROCEDURE

a simple loop gastro-ileal bypass is added to the sleeve procedure.

Also known as: SASI bypass - Santoro's operation - sleeve gastrectomy with transit bipartite - SG þ TB
SASI bypass group
Laparoscopic sleeve gastrectomyPROCEDURE

Conventional sleeve gastrectomy using endoscopic stapler

Laparoscopic sleeve gastrectomy group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Morbid Obesity (BMI ≥ 40 kg/m2) or ( ≥ 35 kg/m2 with associated co-morbidity e.g. type 2 diabetes, joint problems …)
  • Age ≥ 18 and \< 60
  • Failure to achieve adequate and consistent weight loss for at least one year while being followed up by a dietitian.

You may not qualify if:

  • Patients BMI \< 35kg/m2
  • Patients who managed to achieve consistent weight loss by diet control.
  • Contra-indications to laparoscopic surgery e.g. intolerance to general anesthesia, coagulopathy or an associated condition that requires laparotomy.
  • Contra-indications to gastrectomy e.g. gastric ulcer, hiatal hernia or gastro-esophageal reflux disease.
  • Previous laparotomy or bariatric procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Elsharkia, 44511, Egypt

Location

Related Publications (10)

  • Wang Y, Mi J, Shan XY, Wang QJ, Ge KY. Is China facing an obesity epidemic and the consequences? The trends in obesity and chronic disease in China. Int J Obes (Lond). 2007 Jan;31(1):177-88. doi: 10.1038/sj.ijo.0803354. Epub 2006 May 2.

    PMID: 16652128BACKGROUND

  • Herron DM. The surgical management of severe obesity. Mt Sinai J Med. 2004 Jan;71(1):63-71.

    PMID: 14770252BACKGROUND

  • Santoro S, Milleo FQ, Malzoni CE, Klajner S, Borges PC, Santo MA, Campos FG, Artoni RF. Enterohormonal changes after digestive adaptation: five-year results of a surgical proposal to treat obesity and associated diseases. Obes Surg. 2008 Jan;18(1):17-26. doi: 10.1007/s11695-007-9371-0. Epub 2007 Dec 15.

    PMID: 18080721BACKGROUND

  • Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):469-75. doi: 10.1016/j.soard.2009.05.011. Epub 2009 Jun 9. No abstract available.

    PMID: 19632646BACKGROUND

  • Fujioka K. Follow-up of nutritional and metabolic problems after bariatric surgery. Diabetes Care. 2005 Feb;28(2):481-4. doi: 10.2337/diacare.28.2.481.

    PMID: 15677821BACKGROUND

  • Drazen DL, Woods SC. Peripheral signals in the control of satiety and hunger. Curr Opin Clin Nutr Metab Care. 2003 Nov;6(6):621-9. doi: 10.1097/00075197-200311000-00003.

    PMID: 14557791BACKGROUND

  • Casella G, Soricelli E, Rizzello M, Trentino P, Fiocca F, Fantini A, Salvatori FM, Basso N. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Jul;19(7):821-6. doi: 10.1007/s11695-009-9840-8. Epub 2009 Apr 21.

    PMID: 19381737BACKGROUND

  • Mui WL, Lee DW, Lam KK. Laparoscopic sleeve gastrectomy with loop bipartition: A novel metabolic operation in treating obese type II diabetes mellitus. Int J Surg Case Rep. 2014;5(2):56-8. doi: 10.1016/j.ijscr.2013.12.002. Epub 2013 Dec 10.

    PMID: 24441436BACKGROUND

  • Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0.

    PMID: 22609843BACKGROUND

  • Greco F, Tacchino R. Ileal food diversion: a simple, powerful and easily revisable and reversible single-anastomosis gastric bypass. Obes Surg. 2015 Apr;25(4):680-6. doi: 10.1007/s11695-014-1436-2.

    PMID: 25236398BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Masking cannot be applied as both patient and surgeons must be fully informed and consenting regarding the procedure of choice, and the possible outcomes and complications
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomized controlled trial, where patients are assigned to one of two kinds of bariatric procedures, and results are compared between both groups
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of general surgery, Master degree, MD Candidate

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 6, 2020

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

May 1, 2020

Last Updated

January 6, 2020

Record last verified: 2019-12

Locations

EG(1)